Cereno broadens focus for its experimental lung therapy to PH-ILD
Pulmonary hypertension tied to lung scarring becomes new focus area
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Cereno Scientific announced it will broaden development of its experimental treatment CS014 to include pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Cereno had previously focused development of CS014 on idiopathic pulmonary fibrosis (IPF), a condition marked by progressive scarring (fibrosis) of the lungs with no known cause. IPF is one type of interstitial lung disease (ILD), a broader group of disorders that involve lung scarring.
People with ILD can also develop pulmonary hypertension, a condition marked by high blood pressure in the vessels that carry blood from the heart to the lungs.
Why PH-ILD is a key unmet need
Pulmonary hypertension associated with interstitial lung disease, known as PH-ILD, is linked to markedly worse outcomes, including faster disease progression and limited treatment options. By expanding development of CS014 to PH-ILD alongside IPF, Cereno aims to accelerate the therapy’s development.
“Broadening the development focus for CS014 to PH-ILD is a natural and scientifically driven evolution. It enables us to target a severe condition with very limited treatment options and is expected to strengthen the clinical and strategic positioning of CS014 without changing its underlying scientific rationale or long-term development focus,” Sten R. Sörensen, CEO of Cereno, said in a company press release. “The underlying rationale for this strategic focus is that we believe it will enable us to get CS014 faster to market at lower cost and with a higher probability of success.”
CS014 aims to treat lung diseases by modulating epigenetic pathways, meaning it influences how genes are turned on or off in cells. Specifically, the therapy targets histone deacetylases (HDACs), proteins that affect how DNA is packaged inside cells, which in turn can influence gene activity.
Cereno has completed a Phase 1 trial in healthy volunteers, which showed CS014 had a favorable safety profile and was well tolerated. A Phase 2 study is planned to be initiated in early 2027, though further details have not yet been disclosed.
“CS014 targets key [disease-driving] processes that are shared across fibrotic lung disease and pulmonary vascular disease,” said Rahul Agrawal, Cereno’s chief medical officer and head of research and development. “By broadening the development focus to PH-ILD, we can design a Phase II study that better reflects real-world disease biology and for patients with worse prognosis.”
Cereno’s broader development efforts
In parallel, Cereno’s portfolio also includes CS1, a reformulation of an anti-seizure medication called valproic acid, which has been reported to show pressure-relieving, anti-scarring, and anti-inflammatory effects in earlier studies. The company currently has an expanded access program for CS1, which is intended to provide access to the therapy while gathering additional safety data and clinical experience that may support regulatory discussions and future clinical trial planning.
In a Phase 2a study in adults with pulmonary arterial hypertension (PAH), CS1 was reported to be safe and generally well tolerated. The study also found stabilization or improvement in REVEAL risk scores, a tool used to estimate mortality risk in PAH, and lower pulmonary artery pressure in about two-thirds of the participants.
